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Table 8 How often is the risk assessment revisited? (Participants may have provided multiple answers; n = 21 Clinical Trials Units)

From: An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units

  CTIMPs Non-CTIMPs
At a fixed time point (e.g., yearly) 9 5
Routinely after each protocol amendment 10 10
In reaction to a specific issue/event 12 13
Not applicable 2 4
  1. Abbreviation: CTIMP Clinical Trial of an Investigational Medicinal Product